DEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE- dextromethorphan polistirex suspension

dextromethorphan polistirex extended release by

Drug Labeling and Warnings

dextromethorphan polistirex extended release by is a Otc medication manufactured, distributed, or labeled by Unit Dose Services. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Purpose

Cough suppressant

Uses

temporarily relieves

• cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
• the impulse to cough to help you get to sleep

Warnings

Do not use

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.

Ask a doctor before use if you have

• chronic cough that lasts as occurs with smoking, asthma or emphysema
• cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if

• side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
• cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

• shake bottle well before use
• measure only with dosing cup provided
• do not use dosing cup with other products
• dose as follows or as directed by doctor
• mL = milliliter

• adults and children 12 years of age and over:

  10 mL every 12 hours, not to exceed 20 mL in 24 hours

• children 6 to under 12 years of age:

  5 mL every 12 hours, not to exceed 10 mL in 24 hours

• children 4 to under 6 years of age:

  2.5 mL every 12 hours, not to exceed 5 mL in 24 hours

• children under 4 years of age:

  do not use

Other information

• each 5 mL contains: sodium 5 mg
• store at 20° to 25°C (68° to 77°F)
• dosing cup provided

Inactive Ingredients

D&C Red #30 aluminum lake, D&C Yellow #10 aluminum lake, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum

Questions or comments?

1-800-719-9260

HOW SUPPLIED

Product: 50436-0433

NDC: 50436-0433-1 89 mL in a BOTTLE

DEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION

INGREDIENTS AND APPEARANCE

DEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE 
dextromethorphan polistirex suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50436-0433(NDC:45802-433)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
POLISTIREX (UNII: 5H9W9GTW27)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYVINYL ACETATE (UNII: 32K497ZK2U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)
SUCROSE (UNII: C151H8M554)
TARTARIC ACID (UNII: W4888I119H)
TRAGACANTH (UNII: 2944357O2O)
TRIACETIN (UNII: XHX3C3X673)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50436-0433-1	1 in 1 CARTON	07/13/2017
1		89 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091135	09/10/2012

Labeler - Unit Dose Services (831995316)

Establishment
Name	Address	ID/FEI	Business Operations
Unit Dose Services		831995316	RELABEL(50436-0433)